Combination immunotherapy for children and young adults with recently-diagnosed type 1 diabetes

Effect of abatacept with or without nasal insulin on beta cell function in children and young adults with recently-diagnosed type 1 diabetes

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622001236785

Acronym

IAA Trial

Enrollment

Registered

2022-09-13

Start date

2022-11-01

Completion date

2023-10-31

Last updated

2022-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will determine if the combination of abatacept and nasal insulin is more effective than abatacept therapy alone to preserve beta cell function in people who have recently been diagnosed with type 1 diabetes. It will involve 62 children and young adults who will be randomly assigned to receive 48 weeks’ treatment with either abatacept and nasal insulin or abatacept and nasal placebo.

Interventions

Abatacept 125mg weekly by subcutaneous injection for 48 doses combined with nasal insulin (100U/mL) dosed as 4x100mcl sprays (2 per nostril) daily for 10 consecutive days, starting on the day of the first abatacept injection, and then on two consecutive days each week for another 46 weeks. Adherence determined by review of home diary and inspection of returned syringes and spray bottles.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

6 Years to 21 Years

Healthy volunteers

Inclusion criteria

Age between 6 and 21 years and weight>20kg at Screening Visit; diabetes mellitus diagnosed within 100 days of first dose of study drugs; presence of at least one islet autoantibody; random C-peptide >0.3nmol/l; using CGM and willing to do this for the duration of the study; demonstrated ability to record home glucose and insulin doses; willing to forego other forms of experimental treatment during the study; up to date with recommended vaccinations; willing to postpone live vaccine immunisations for 3 months after end of treatment.

Exclusion criteria

Clinical or laboratory evidence of active infection other than localised skin infection; immunodeficiency or chronic use of immunosuppressive drugs other than topical or inhaled glucocorticoid; vaccination with live or dead virus within 4 weeks of the first dose of study drugs; history of malignancy; pregnant or lactating, or of child-bearing potential not using an effective method of contraception; any pathology of the nasal passages that would contraindicate nasal spray treatment; any condition that would interfere with study conduct or participant safety

Outcome results